Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
Verified April 2014 by Guidant Corporation
Information provided by (Responsible Party):
First received: October 15, 2012
Last updated: April 30, 2014
Last verified: April 2014
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
||Time Perspective: Prospective
||Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Primary Outcome Measures:
- Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study.
Secondary Outcome Measures:
- Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
A multivariate model will be used to find the independent association with the combined primary endpoint, RYTHMIQ algorithm and other patient characteristics.
Variables of interests include (but are not limited to): primary pacing indication (SND vs AVB), degree of AVB, age, gender, underlying disease, use of Betablockers, history of atrial fibrillation, LVEF, NYHA class, RV lead position, type of sensors used.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
RYTHMIQ study group
Historical control from OPTI-MIND
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
- Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
- Patients with 3rd degree AV block
- Patients with permanent AF
- Patients followed up remotely with remote patient management system.
- Patients who are unable to be followed up by the participating centers for a period of two years
- Patients who have a current device implanted for more than 15 days
- Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01715558
No publications provided
History of Changes
|Other Study ID Numbers:
||CDM00053871 / 90942887
|Study First Received:
||October 15, 2012
||April 30, 2014
||Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Slovakia: State Institute for Drug Control
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014